# US 10,369,203 B2 · Crystallized oxalate decarboxylase and methods of use

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- Number: US 10,369,203 B2
- Document ID: US10369203B2
- Status: Granted
- Kind: B2
- Application number: 15/790,556
- Filed: 2017-10-23
- Published: 2018-08-02
- Granted: 2019-08-06
- Earliest claimed: 2006-08-02
- Assignees: Allena Pharmaceuticals, Inc.
- Applicants: Allena Pharmaceuticals, Inc.
- Inventors: Bhami C. Shenoy; Teresa G. Cachero; John Shin; Lekai Zhang; Aftab Rashid; Danica Grujic; Reena J. Patel; Margaret Ellen McGrath
- Web page: https://patentgrep.com/patent/US10369203B2

## CPC

- A61K 38/51: Lyases (4)
- A61K 9/0034: {Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants}
- A61M 1/16: with membranes
- A61M 1/3687: {Chemical treatment (A61M1/3675 takes precedence)}
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/12: Antidiarrhoeals
- A61P 1/14: Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 1/18: for pancreatic disorders, e.g. pancreatic enzymes
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61P 7/08: Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock (artificial tears A61P27/04)
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 13/00: Drugs for disorders of the urinary system
- A61P 13/02: of urine or of the urinary tract, e.g. urine acidifiers
- A61P 13/04: for urolithiasis
- A61P 13/12: of the kidneys
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 19/00: Drugs for skeletal disorders
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12N 9/88: Lyases (4.)
- C12Q 1/527: involving lyase
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- A61M 2202/0413: Blood
- A61M 2205/75: with filters
- C07K 2299/00: Coordinates from 3D structures of peptides, e.g. proteins or enzymes
- C12Y 401/01002: Oxalate decarboxylase (4.1.1.2)
- G01N 2333/988: Lyases (4.), e.g. aldolases, heparinase, enolases, fumarase
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- C12Y: ENZYMES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Oxalate decarboxylase crystals, including stabilized crystals, such as cross-linked crystals of oxalate decarboxylase, are disclosed. Methods to treat a disorder associated with elevated oxalate concentration using oxalate decarboxylase crystals are also disclosed. Additionally disclosed are methods of producing protein crystals.

## Claims

### Claim 1

A capsule comprising a pharmaceutical composition that comprises spray-dried, biologically active oxalate decarboxylase crystals having a moisture content of less than 5% by weight, and a filler, wherein the oxalate decarboxylase is uncrosslinked and is capable of converting oxalate to formate.

### Claim 2 (depends on 1)

The capsule of claim 1, wherein the oxalate decarboxylase crystals are about 1 μm to about 25 μm in length.

### Claim 3 (depends on 1)

The capsule of claim 1, wherein the filler comprises one or more of a sugar, sugar alcohol, viscosity increasing agent, wetting agent, solubilizing agent, buffer salt, and emulsifying agent.

### Claim 4 (depends on 1)

The capsule of claim 1, wherein the filler is a sugar or sugar alcohol.

### Claim 5 (depends on 1)

The capsule of claim 1, wherein the oxalate decarboxylase retains at least 50% of its activity upon exposure to an aqueous solution having a pH of about 6.8 for 1 hour.

### Claim 6 (depends on 1)

The capsule of claim 1, wherein the oxalate decarboxylase is a recombinant oxalate decarboxylase.

### Claim 7 (depends on 1)

The capsule of claim 1, wherein the oxalate decarboxylase has an amino acid sequence that has at least 95% sequence identity with SEQ ID NO: 3.